Description of Event or Problem · 1
THE PROBE BOOT DISTAL END OF PROBE HAD COME AWAY FROM THE REST OF THE PROBE BODY. THE HOSPITAL WAS THEN PHONED BACK AND THE CHARGE NURSE STATED THE FOLLOWING: WE HAD INSERTED THE PROBE THIS MORNING AT AROUND 10 A.M. AND IT WAS WORKING FINE. AS RPTR HAD ANOTHER PT WITH A PROBE IN, RPTR WAS USING THE CARDIOQ MONITOR BETWEEN THE TWO PTS. RPTR WAS USING THE CARDIOQ THIS AFTERNOON ON THE PT, BUT RPTR WAS UNABLE TO GET A GOOD SIGNAL AS BEFORE. RPTR TOOK THE PROBE OUT OF THE PT, AS RPTR WAS NOT GOING TO ALTER ANY MORE THERAPY FOR NOW. RPTR CLEANED IT WITH A TISSUE SO THAT RPTR COULD PUT IT BACK IN A BAG AND KEEP IT IN CASE RPTR NEEDED TO USE IT AGAIN ON THE PT. WHILE RPTR WAS CLEANING IT, THE TIP CAME OFF IN THEIR HAND. WAS NOT USING EXCESS FORCE, JUST WIPING IT. THE NEXT DAY PROBE WAS COLLECTED FROM THE UNIT. CHARGE NURSE HAS COMPLETED AN INTERNAL INCIDENT REPORT FORM. CUSTOMER COMPLAINT DATABASE CHECKED FOR PREVIOUS OCCURRENCES. HISTORICALLY THIS IS THE FIRST INCIDENT OF THIS TYPE OF FAILURE. AS A PRECAUTIONARY MEASURE REMAINING QUANTITIES, LOTS 1056 AND 1058, IN HOUSE CONTAINING BATCHES EITHER SIDE OF BATCH 2212 I.E. BATCHES 2211 AND 2213 HAVE BEEN QUARANTINED. A MEETING WITH THE CHARGE NURSE INVOLVED SCHEDULED TO DISCUSS CIRCUMSTANCES OF THE INCIDENT. THE SERIAL NUMBER OF THE PROBE WAS TRACED TO DEVICE HISTORY RECORD BACTH NO 2212. THIS INDICATED THAT COMPETENT OPERATORS HAD BUILT THE PROBES AND THAT THERE HAD BEEN NO PROBLEMS DURING THEIR MANUFACTURE I.E. OUT OF A QUANTITY OF 100 PROBES BUILT 100 WERE RELEASED TO STORES WITH NO REJECT OR SCRAP. BATCH NUMBERS EITHER SIDE OF THIS BATCH 2211 AND 2213 WERE TRACED TO LOT 1057 -TOTAL QUANTITY 1991-. NONE OF LOT 1057 WAS SHIPPED TO THE UNITED STATES. STERILIZATION RESULTS WERE ALSO REVIEWED AND ROUTINE RESIDUAL ANALYSIS RESULTS INDICATED THAT ETHYLENE OXIDE, 2-CHLORETHANOL AND ETHANEDIOL WERE ALL WITHIN PERMITTED LIMITS. PROBE INFO: PROBE INFO DOWNLOADED FROM THE CARDIOQ MONITOR INDICATES THAT THE PROBE WAS FIRST USED FOR A TOTAL MONITORING TIME OF 5 TO 6 HOURS. VISUAL INSPECTION: SILICONE COVER WHICH CONTAINS PLASTIC PROBE TIP ON WHICH PIEZOELECTRIC CRYSTAL PLATE PAIRS ARE MOUNTED- HAD BEEN COMPLETELY SEPARATED I.E. NOT ONLY HAD THE GLUED BOND BETWEEN THE PROBE TUBE AND THE BOOT WAS BROKEN BUT ALSO THE COAXIAL SUPPLY CABLE -CONTAINING A RED AND BLUE COATED CONDUCTORS- WHICH SUPPLY THE PIEZOELECTRIC CRYSTAL ASSEMBLY. INSPECTION OF THE GLUING PROCESS FOUND THAT SUFFICIENT GLUE HAD BEEN USED TO BOND BOTH THE PROBE TUBE AND BOOT TOGETHER AND ONLY TWO SMALL AIR BUBBLES COULD BE FOUND IN THE GLUE THAT WOULD NOT HAVE COMPROMISED THE BOND STRENGTH AND WOULD NOT HAVE BEEN VISIBLE DURING FINAL INSPECTION. TRACES OF GLUE WERE ALSO FOUND ON THE OUTSIDE OF THE MONOCOIL PROBE SPRING AND ON THE INSIDE OF THE PROBE BOOT ALSO INDICATING A GOOD BOND. GLUE HAD ALSO WICKED DOWN INTO THE INSIDE OF THE MONOCOIL SECURELY BONDING THE COAXIAL SUPPLY CABLE IN PLACE. THE PROBE BOOT WAS THEN DISSECTED AND THE RED AND BLUE WIRES WERE FOUND TO HAVE BEEN BROKEN IN SUCH A WAY AS TO INDICATE THE USE OF A CONSIDERABLE TENSILE LONGITUDINAL FORCE TO THE PROBE BODY. PROPOSED CORRECTIVE ACTION: PROBE REPLACED FREE OF CHARGE AS A GOOD WILL GESTURE. 6 PROBES FROM LOT 1057 -6 OF 1991- WERE TESTED TO CHECK BONDING STRENGTH BETWEEN PROBE BOOT AND SHAFT. PROPOSED PREVENTATIVE ACTION: 1-INTRODUCE AN INTERMEDIATE PULL TEST IN OESOPHAGEAL DOPPLER PROBE FINAL INSPECTION AND CLEAN PROCEDURE 9050-1208. 2-INTRODUCE TENSILE TESTING OF ONE PROBE PER BATCH -1 PER 100 PROBES- BEFORE STERILIZATION USING A MOTOR DRIVEN MICRO FORCE GAUGE. 3-MONITOR CUSTOMER COMPLAINTS DATABASE FOR THIS TYPE OF INCIDENT. HISTORICALLY THIS IS THE FIRST INCIDENT OF THIS TYPE OF FAILURE. PRELIMINARY CONCLUSION: AT THIS STAGE MFR CONCLUDES FROM THE TECHNICAL INVESTIGATION CONDUCTED THAT THE INCIDENT OCCURRED THROUGH GROSS MISTREATMENT OF THE PROBE BY THE CUSTOMER. A MEETING WITH THE CHARGE NURSE INVOLVED IS SCHEDULED.